The present invention relates to a device for use by individuals having conditions, resulting in excessive saliva, improper swallowing functions or other conditions or disorders resulting in uncontrolled drooling. Particularly this relates to a portable hygienic saliva compensation device and method.
Drooling is abnormal for people beyond the age of toddlers. For some people with a variety of neurological conditions, drooling is a chronic problem which cannot be remedied by standard intervention methods. There is no definitive research data on the number of people with drooling problems, but the literature estimates that ten percent (10%) of all people with cerebral palsy have unwanted drooling. Individuals with conditions such as head injury, Amyotropic Lateral Sclerosis, and other degenerative neurological diseases can also have a drooling problem.
Previously, there has not been an acceptable device for reliable collection of saliva overflow during normal activities of a person with a drooling problem and that includes research and training capabilities. Without a truly portable and convenient apparatus for the collection of saliva, accurate data related to this problem cannot be easily obtained. Not only would a device be beneficial for people with excess saliva overflow but also reliable collection of saliva overflow is essential for determining the effectiveness of various intervention strategies. Such a device could also be useful as a research tool for physicians and other clinicians in their research to determine the effectiveness of different behavioral, pharmaceutical, and surgical techniques and intervention in dealing with this problem. Moreover, a device useful for clean, safe hygiene and research, and a device that is also useful as a training tool to assist in teaching people better behavioral techniques for swallowing and other saliva compensation activities is desirable and has not previously been provided.
Applicants"" invention addresses many of the foregoing needs by providing a modularized, assistive technology hygienic saliva compensation device which is portable by the user and which the user can operate to clean his or her mouth, lips, chin and shirt front of unwanted saliva.
It is the object of the present invention to provide a portable hygienic saliva compensation device. Such a device is desirably discreet, aesthetically acceptable to the user, quiet and reliable.
It is the further object of the invention to provide a hygienic saliva compensation device which is modularized and portable so that it can be carried by the user in a backpack, or fanny pack, or attached to a wheelchair or moveable from one chair to another or from one table to another.
It is the further object of the present invention to provide a device which functions as a vacuum for saliva overflow, collects saliva drool for disposal and/or measurement purposes.
It is the object of the present invention to provide a saliva compensation device which is hygienic and easy to clean, simple for users and for care givers to operate, is nonirritating to the skin, and helps reduce odor problems often associated with excessive drooling.
It is the further object of the present invention to comfortably accommodate natural movements of the user including head, neck, torso, and body movements.
It is the further object of the present invention to provide a saliva compensation device which is designed for conducting research and also for training users to swallow, including variable timing devices and a flexible, embedded cuing system.
It is the further object of the present invention to provide a device useful for clinicians and researchers to determine differences in the amount of drool collected due to different types of clinical or physical interventions by monitoring the amount of saliva overflow collected in a container.
It is an object of the present invention to provide integrated software and hardware in a saliva compensation device to collect data for later analysis on a variety of variables, including natural activities of the user, and such as head tilting and swallowing, the number and type of cues given to the user, and number of times and the duration that the vacuum pump is activated. The software and hardware work together to determine and to indicate when the drool collection container or reservoir reaches a full condition.
It is further an object to provide a device with capabilities of being preprogrammed with a computer, of recording operations data in a portable unit, of providing a convenient downloading for analysis in a personal computer (PC) through a data communication port, such as an RS-232 serial port, a parallel port, or an infrared communication port.
It is another object to provide a portable device having a programmable, integrated circuit (PIC) capable of receiving downloaded programming instructions for operation, cuing, monitoring of device functions, monitoring of physiological conditions and physical actions of a user. Uploading Uploading and downloading of instructions from software or another machine, such as a personal computer, is advantageous for research, teaching, and controlling or compensating for excessive salivation.
It is the further object of the present invention to provide an electromechanical, computerized device using various molded silicone parts, molded plastic parts, flexible tubing, flexible wiring, a lightweight pumping unit, a portable power source, and a pre-manufactured or injection-molded carrying case for holding electronics, batteries, pumps, containers and other components in a portable unit. The modular construction preferably allows for the selection of one or more of several types of collection units. The device is selectably useable and programable with clinical, teaching and research software.
In one embodiment the device may be manufactured in a configuration primarily for use by the buyer. Such a configuration may include the basic pump, collection unit and carrying case. The essential user unit would preferably include a pump, a collection bottle, a battery, control electronics and one or more collectors. For example, the user unit may advantageously include capabilities of accepting more than one of several types of collection units. It would be small and lightweight and need not include research or training capacity. The user would typically be provided with a shirt collection unit, a face collection unit, a wrist collection unit, a handheld collection unit and/or an intra-oral collection unit. Automatic activation, user switch or user button activation is provided. The unit may have a switch or a combination of switches. Types of switches include a user switch to turn the pumping unit xe2x80x9conxe2x80x9d and xe2x80x9coff,xe2x80x9d an automatic resistance sensor to detect the presence or absence of saliva in a collector, a programable xe2x80x9ctime-outxe2x80x9d function to turn on at a predetermined interval to automatically turn on the pumping unit for a predetermined time. The absence of saliva in the collector may turn the pump off or a preselected pumping duration can automatically turn the pump off.
In a second embodiment a clinical saliva compensation unit is configureable having clinician activation, as well as multiple input and output connectors to electronic control circuitry. The multiple input and output connectors are convenient and useful for training and research. An onboard Programable Integrated Circuit or PIC is programmable using a PC and data transfer technology. A user can be monitored and evaluated by a clinician and a software module can be provided for data collection and storage. The data can be transferred to other computer devices such as PCs for reconfiguration, data download, analysis, training and/or for research. The timeout function mentioned above may be linked to a sensor of physical activity, such as swallowing, to reset the timer, to otherwise alter the programable automatically-timed pumping activation and to be linked to training activities. Interconnection of any or all of the pump activation mechanisms with optional swallowing detectors is useful for determining whether the pumping is required or whether the pumping duration can be reduced because the user has recently swallowed. Advantageously, programming can be uploaded to the PIC from a clinician""s PC and data can be collected and downloaded to the PC from onboard data collection modules.
In a particularly useful clinical device, the main unit has the two saliva collector ports, clinician switch, user switch, two device activation connectors, an X-10 activation, a speech input/output, an RS-232 link, connector for a swallow frequency device, head tilt switch connector, two sensitivity switches, a power on/off button or switch, a PIC, a collection bottle, batteries and a solenoid valve for controlling a vacuum valve that governs the steering of the vacuum to an appropriate saliva collector.